MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE LTL CEM TIBIAL DRILL; DRILLS

Catalog Number	254500165
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: h3, h6: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This product issue will be addressed through depuy synthes quality system.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed scratches on its cylindrical body, mostly by attempting to assemble the device with its mating component.Devices (tibial drill and drill tower) were returned disassembled and no other cosmetic anomaly was identified on the device surface.Device was sent to the manufacturer for further investigation and confirmed the product issue was traced to the manufacturing process.A dimensional inspection was performed for the tibial drill (d254500165) and device did not meet specifications.A functional test was performed using the returned drill tower (d254500131) as mating device.Test revealed the tibial drill (d254500165) could not be assembled with its mating component as intended as a consequence of the observed damage.It is important to mention that an additional functional test was performed for the device using a depuy synthes sample as mating component: drill tower (d254500131).Test revealed tibial drill could not either be assembled as intended with the sample, confirming the failure on both cases.The overall complaint was confirmed as the observed condition of the attune ltl cem tibial drill would have contributed to the complained device issue.¿ based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: specified dimensions drill central body measured dimensions: drill central body ø = fail.
Event or Problem Description
The instrument is somehow broken/damaged from the beginning (you have to force the drill into the drill tower ¿ very stiff and doesn¿t fit) this is the instrument set that they started to use later because of the missing 4l femur part.

• Brand Name: ATTUNE LTL CEM TIBIAL DRILL
• Common Device Name: DRILLS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24717246
• Report Number: 1818910-2026-05376
• Device Sequence Number: 6121270
• Product Code: HTW
• UDI-Device Identifier: 10603295445647
• UDI-Public: (01)10603295445647(10)NG150580
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 254500165
• Device Lot Number: NG150580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown